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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

ORTEX 033 Thigh bandage — Class I MDR by ORTEX , spol. s r.o.

MD Atlas
ORTEX , spol. s r.o.

EUDAMED last updated this device on May 31, 2026

ORTEX 033 Thigh bandage

85955714ORTEX033NF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTEX , spol. s r.o.
UDI-DI code: 08595571405023
Reference / catalog number: N/A

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View device family (Basic UDI)

Manufacturer information

Organization name: ORTEX , spol. s r.o.
SRN: CZ-MF-000048500
Manufacturer status: Active

Related devices

ORTEX 031A Elastic abdominal belt85955714ORTEX031A6MOn the market ORTEX 031A Elastic abdominal belt85955714ORTEX031A6MOn the market ORTEX 031A Elastic abdominal belt85955714ORTEX031A6MOn the market ORTEX 031A Elastic abdominal belt85955714ORTEX031A6MOn the market ORTEX 031A Elastic abdominal belt85955714ORTEX031A6MOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: ORTEX 033 Thigh bandage
UDI-DI code: 08595571405023
Basic UDI-DI: 85955714ORTEX033NF
Reference / catalog number: N/A
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The bandage is designed to strengthen the thigh muscles and prevent during sports activities.
Additional information URL: https://www.ortexzlin.cz/
Clinical sizes: S-Short

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08595571405023

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y061217THIGH ORTHOSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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